FDA Adverse Event
Malfunction
Summary report: N
CLEAR, PVC CONTRAST INJECTION LINE
MDR report key: 1635988
·
Received March 12, 2010
Report
- Report Number
- 1721504-2010-00058
- Event Type
- Malfunction
- Date Received
- March 12, 2010
- Date of Event
- December 7, 2009
- Report Date
- February 15, 2010
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DXJ
- PMA / PMN Number
- K883718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: DEVICE EVAL IS IN PROGRESS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATABASE REVIEW FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. DEVICE HISTORY RECORD WAS REVIEWED. COMPLAINT DATA BASE WAS REVIEWED. CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THEY WERE NOT ABLE TO SUFFICIENTLY TIGHTEN THE HIGH PRESSURE TUBING TO THE CONTRAST SYRINGE. WHEN RUNNING THE INJECTOR, THE TUBING POPPED OFF THE SYRINGE AND CONTRAST SPRAYED EVERYWHERE. THERE WAS NO REPORT OF HARM OR INJURY. THIS IS THE SECOND OF TWO EVENTS, REFERENCE 1721504-2010-00057 FOR THE REPORTED FIRST EVENT FROM THIS CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEAR, PVC CONTRAST INJECTION LINE | DISPLAY, CATHODE-RAY TUBE, MEDICAL | DXJ | MERIT MEDICAL SYSTEMS, INC. | F706485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTRAST MEDIA |